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Ixora-peds: Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03073200
Collaborator
(none)
201
Enrollment
69
Locations
3
Arms
47.8
Actual Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date :
Mar 28, 2017
Actual Primary Completion Date :
Feb 7, 2019
Actual Study Completion Date :
Mar 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ixekizumab

Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.

Drug: Ixekizumab
Administered SC
Other Names:
  • LY2439821

    		•
    Placebo Comparator: Placebo

    Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.

    Drug: Placebo
    Administered SC
    Experimental: Open-Label Etanercept

    Etanercept given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period. Participants will only be randomized to etanercept in countries where it is approved for severe pediatric psoriasis treatment.

    Drug: Etanercept
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab) [Week 12]

      PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

    2. Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab) [Week 12]

      Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

    Secondary Outcome Measures

    1. Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [Week 12]

      PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

    2. Percentage of Participants With a sPGA (0) [Week 12]

      Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis. An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis.

    3. Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [Week 12]

      PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

    4. Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [Week 4]

      PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

    5. Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) [Week 4]

      Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

    6. Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4 [Week 12]

      Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.

    7. Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1) [Week 12]

      DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).

    8. Change From Baseline on the Nail Psoriasis Severity Index (NAPSI) [Baseline, Week 12]

      NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis & nail matrix psoriasis by area of involvement in the nail unit. Both fingernail & toenail involvement were assessed.The nail is divided with imaginary horizontal & longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) & nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed & nail matrix psoriasis in each quadrant: 0 = None = present in one quadrant of nail = present in two quadrants of nail = present in three quadrants of nail = present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed & nail matrix from each quadrant (maximum of 8). Each nail is evaluated, & the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)

    9. Change From Baseline on the Psoriasis Scalp Severity Index (PSSI) [Baseline, Week 12]

      The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent = Slight = Moderate = Severe = Severest Possible Percent of Scalp Involved: = <10% = 10% - 29% = 30% - 49% = 50% - 69% = 70% - 89% = 90% - 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease). LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.

    10. Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI) [Baseline, Week 12]

      PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows: Erythema (E), Induration (I), & Desquamation (D):0 = None, 1 = Slight, 2 = Moderate, 3 = Severe, 4 = Very Severe Percent of Palm and Sole Area Covered: 0 = None, 1 = <10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease).

    11. Number of Participants With Anti-Ixekizumab Antibodies [Baseline through Week 48]

      A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as: a participant with a >= 4-fold increase over a positive baseline antibody titer; or for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10.

    12. Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) [Week 12]

      Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).

    13. Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries) [Week 12]

      PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

    14. Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries) [Week 12]

      Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.

    • Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global Assessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.

    • Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.

    • Male subjects agree to use a reliable method of birth control during the study.

    • Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.

    • Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.

    • All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.

    Exclusion Criteria:

    • Have pustular, erythrodermic, and/or guttate forms of psoriasis.

    • Have drug-induced psoriasis.

    • Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).

    • Participants with a documented history of immune deficiency syndrome.

    • Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.

    • Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.

    • Have used any therapeutic agent targeted at reducing interleukin-17.

    • Have received other therapies within the specified time frames prior to screening (see below):

    • adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives.

    • systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralen plus ultraviolet A]) in the previous 4 weeks.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 Tien Q. Nguyen, MD inc. DBA First OC Dermatology Fountain Valley California United States 92708
    3 Children's National Medical Center Washington District of Columbia United States 20010
    4 Olympian Clinical Research Clearwater Florida United States 33756
    5 Solutions Through Advanced Research, Inc. Jacksonville Florida United States 32256
    6 University of South Florida Tampa Florida United States 33612
    7 Forward Clinical Trials, Inc Tampa Florida United States 33624
    8 Advanced Medical Research Sandy Springs Georgia United States 30328
    9 Northwestern University Chicago Illinois United States 60611
    10 University of Chicago Medical Center Chicago Illinois United States 60637
    11 Arlington Dermatology Rolling Meadows Illinois United States 60008
    12 The South Bend Clinic South Bend Indiana United States 46617
    13 University of Missouri Columbia Missouri United States 65212
    14 SSM Health Cardinal Glennon Children's Hospital Saint Louis Missouri United States 63104
    15 Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey United States 08520
    16 University of North Carolina Dermatology and skin Cancer Cen Chapel Hill North Carolina United States 27516
    17 Wright State Physicians Dermatology Fairborn Ohio United States 45324
    18 Ohio State Univ College Of Medicine Gahanna Ohio United States 43230
    19 Oregon Dermatology and Research Center Portland Oregon United States 97210
    20 Oregon Health and Science University Portland Oregon United States 97239
    21 Dermatology and Skin Surgery Center Exton Pennsylvania United States 19341
    22 Medical University of South Carolina Charleston South Carolina United States 29425
    23 Modern Research Associates PLLC Dallas Texas United States 75231
    24 Texas Dermatology and Laser Specialists San Antonio Texas United States 78218
    25 Virginia Clinical Research Norfolk Virginia United States 23502
    26 Centro de Investigaciones Metabólicas (CINME) Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1056ABJ
    27 Fundación Estudios Clínicos- Servicio de Dermatología Rosario Santa Fe Argentina 5200
    28 Instituto de Neumonología y Dermatología Buenos Aires Argentina C1425BEA
    29 Psoriahue Medicina Interdisciplinaria Buenos Aires Argentina C1425DKG
    30 Institute for Skin Advancement Calgary Alberta Canada T3A 2N1
    31 Lynderm Research Inc Markham Ontario Canada L3P1X2
    32 K. Papp Clinical Research Inc Waterloo Ontario Canada N2J 1C4
    33 Hospital Ste Justine Montreal Quebec Canada H3T 1C5
    34 Detska fakultni nemocnice Brno Czechia 613 00
    35 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    36 Fakultni Nemocnice Plzen Plzen-Bory Czechia 305 99
    37 Fakultni nemocnice Kralovske Vinohrady Praha 10 Czechia 100 34
    38 Nemocnice Na Bulovce Praha 8 Czechia 180 81
    39 LF UK - Fakultni poliklinika Praha Czechia 120 00
    40 Centre hospitalier universitaire Pellegrin Bordeaux France 33076
    41 Hôpital Femme Mère Enfant Bron France 69500
    42 CHU de Nice Hopital de L'Archet Nice France 06202
    43 Universitätsklinikum Erlangen Erlangen Bayern Germany 91054
    44 Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen Germany 60590
    45 Universitätsklinikum Münster Münster Nordrhein-Westfalen Germany 48149
    46 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Rheinland-Pfalz Germany 55131
    47 ISA GmbH Berlin Germany 10789
    48 SZTE AOK Borgyogyaszati es Allergologiai Klinika Szeged Csongrad Hungary 6720
    49 Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika Debrecen Hajdu-Bihar Hungary 4032
    50 Allergo-Derm Bakos Kft Szolnok Jasz-Nagykun-Szolnok Hungary 5000
    51 Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak Budapest Hungary 1123
    52 Oroshaza Varosi Onkormanyzat Korhaza Oroshaza Hungary 5901
    53 Hospital Infantil de Mexico Ciudad de Mexico Federal District Mexico 06720
    54 Hospital Univ. Dr. Jose Eleuterio Gonzalez Monterrey Nuevo León Mexico 64460
    55 RM Pharma Specialists S.A. de C.V. Distrito Federal Mexico 3100
    56 Arke Estudios Clinicos S.A. de C.V. Veracruz Mexico 91910
    57 Universitair Medisch Centrum St Radboud Nijmegen Nijmegen Netherlands 6525 GL
    58 "Dermed" Centrum Medyczne Sp. z o.o. Lodz Poland 90-265
    59 Centralny Szpital Kliniczny MSW Warszawa Poland 02-507
    60 DermMEDICA Sp. z o.o. Wroclaw Poland 51-318
    61 Office of Dr. Samuel Sanchez PSC Caguas Puerto Rico 00727
    62 Grupo Dermatologico de Carolina Carolina Puerto Rico 00985
    63 Ponce School of Medicine CAIMED Center Ponce Puerto Rico 00716
    64 GCM Medical Group PSC San Juan Puerto Rico 00917
    65 GBUZ Clinical dermatology and venereological dispensary Krasnodar Russian Federation 350000
    66 Center of Children's Health Moscow Russian Federation 119991
    67 Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona Spain 08950
    68 Hospital Universitario 12 de Octubre Madrid Spain 28041
    69 Hospital Universitario La Paz Madrid Spain 28046

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03073200
    Other Study ID Numbers:
    • 16367
    • I1F-MC-RHCD
    • 2016-003331-38
    First Posted:
    Mar 8, 2017
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Aug 16, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    children
    psoriasis treatment
    adolescents
    Additional relevant MeSH terms:
    Psoriasis
    Etanercept
    Ixekizumab

    Study Results

    Participant Flow

    Recruitment Details Double-Blind Treatment Period (Week 0 to Week 12), Open-Label Maintenance Period (Week 12 to Week 60), Extension Period (Week 60 to Week 108) followed by post-treatment follow-up period occurring from last treatment visit (week 108), or Early Termination Visit (ETV) for up to 24 weeks following that visit. Etanercept (ETN) is reference control group occurred only in Etanercept approved countries.
    Pre-assignment Detail The 48-Week Double-Blind, Randomized Withdrawal Period occurs from Week 60 to Week 108 for participants in the Europe who meet the response criterion at Week 60 (defined as sPGA [0,1]).
    Arm/Group Title PBO (Double-Blinded Treatment Period) IXEQ4W (Double-Blinded Treatment Period) ETN (Double-Blinded Treatment Period) PBO/IXEQ4W (Maintenance Period) IXEQ4W/IXEQ4W (Maintenance Period) ETN/IXEQ4W (Maintenance Period) PBO/IXEQ4W/IXEQ4W (Extension Period) IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) ETN/IXEQ4W/IXEQ4W (Extension Period) PBO (Randomized Withdrawal Period) IXEQ4W (Randomized Withdrawal Period) IXEQ4W_Re-Treatment (Randomized Withdrawal) Period PBO (Post-Treatment Follow-Up) IXEQ4W (Post-Treatment Follow-Up) ETN (Post-Treatment Follow-Up)
    Arm/Group Description Participants received matching placebo (PBO) for Ixekizumab (IXE) by subcutaneous injection. Participants with >50 kilogram (kg) weight received 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants received 0.8 milligrams per kilogram (mg/kg) Etanercept (ETN) not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period. Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period. Participants from EU countries who do not meet the response criterion at Week 60 continued with open-label treatment with ixekizumab. Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels. Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels. Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
    Period Title: Double Blind Treatment Period
    STARTED 56 115 30 0 0 0 0 0 0 0 0 0 0 0 0
    Participants in Etanercept Approved Countries 19 38 30 0 0 0 0 0 0 0 0 0 0 0 0
    COMPLETED 54 114 30 0 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0
    Period Title: Double Blind Treatment Period
    STARTED 0 0 0 53 113 28 0 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 49 109 28 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 4 4 0 0 0 0 0 0 0 0 0 0
    Period Title: Double Blind Treatment Period
    STARTED 0 0 0 0 0 0 34 68 9 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 31 62 7 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 3 6 2 0 0 0 0 0 0
    Period Title: Double Blind Treatment Period
    STARTED 0 0 0 0 0 0 0 0 0 33 34 33 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 33 32 30 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 2 3 0 0 0
    Period Title: Double Blind Treatment Period
    STARTED 0 0 0 0 0 0 0 0 0 0 0 0 6 166 2
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 6 139 1
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 27 1

    Baseline Characteristics

    Arm/Group Title Placebo Ixekizumab Open-label Etanercept Total
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection. Total of all reporting groups
    Overall Participants 56 115 30 201
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    13.1
    (2.79)
    13.7
    (3.14)
    13.7
    (2.95)
    13.5
    (3.02)
    Sex: Female, Male (Count of Participants)
    Female
    36
    64.3%
    63
    54.8%
    18
    60%
    117
    58.2%
    Male
    20
    35.7%
    52
    45.2%
    12
    40%
    84
    41.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    11
    19.6%
    30
    26.1%
    7
    23.3%
    48
    23.9%
    Not Hispanic or Latino
    42
    75%
    82
    71.3%
    23
    76.7%
    147
    73.1%
    Unknown or Not Reported
    3
    5.4%
    3
    2.6%
    0
    0%
    6
    3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    2
    1.7%
    1
    3.3%
    3
    1.5%
    Asian
    2
    3.6%
    4
    3.5%
    0
    0%
    6
    3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    5.4%
    3
    2.6%
    0
    0%
    6
    3%
    White
    45
    80.4%
    95
    82.6%
    25
    83.3%
    165
    82.1%
    More than one race
    3
    5.4%
    10
    8.7%
    3
    10%
    16
    8%
    Unknown or Not Reported
    3
    5.4%
    1
    0.9%
    1
    3.3%
    5
    2.5%
    Region of Enrollment (Count of Participants)
    Puerto Rico
    3
    5.4%
    5
    4.3%
    0
    0%
    8
    4%
    Argentina
    3
    5.4%
    7
    6.1%
    3
    10%
    13
    6.5%
    Hungary
    6
    10.7%
    13
    11.3%
    2
    6.7%
    21
    10.4%
    United States
    22
    39.3%
    42
    36.5%
    0
    0%
    64
    31.8%
    Czechia
    2
    3.6%
    6
    5.2%
    4
    13.3%
    12
    6%
    Spain
    5
    8.9%
    4
    3.5%
    3
    10%
    12
    6%
    Russia
    4
    7.1%
    7
    6.1%
    4
    13.3%
    15
    7.5%
    Canada
    1
    1.8%
    6
    5.2%
    0
    0%
    7
    3.5%
    Netherlands
    0
    0%
    1
    0.9%
    0
    0%
    1
    0.5%
    Poland
    5
    8.9%
    12
    10.4%
    8
    26.7%
    25
    12.4%
    Mexico
    1
    1.8%
    4
    3.5%
    2
    6.7%
    7
    3.5%
    France
    1
    1.8%
    1
    0.9%
    1
    3.3%
    3
    1.5%
    Germany
    3
    5.4%
    7
    6.1%
    3
    10%
    13
    6.5%
    Psoriasis Area Severity Index (PASI) (Score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score on a scale]
    19.73
    (8.010)
    19.75
    (7.509)
    24.78
    (7.448)
    20.49
    (7.81)
    (sPGA) (Score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score on a scale]
    3.5
    (0.63)
    3.6
    (0.61)
    4.1
    (0.31)
    3.63
    (0.61)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)
    Description PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized Participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    25
    44.6%
    88.7
    77.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 63.7
    Confidence Interval (2-Sided) 95%
    51.0 to 76.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)
    Description Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation(NRI). Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    10.7
    19.1%
    80.9
    70.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 70.2
    Confidence Interval (2-Sided) 95%
    59.3 to 81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
    Description PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    5.4
    9.6%
    78.3
    68.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 72.9
    Confidence Interval (2-Sided) 95%
    63.3 to 82.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants With a sPGA (0)
    Description Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis. An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    1.8
    3.2%
    52.2
    45.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 50.4
    Confidence Interval (2-Sided) 95%
    40.6 to 60.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
    Description PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    1.8
    3.2%
    49.6
    43.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 47.8
    Confidence Interval (2-Sided) 95%
    38.0 to 57.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
    Description PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    8.9
    15.9%
    53.9
    46.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 45
    Confidence Interval (2-Sided) 95%
    33.2 to 56.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)
    Description Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    7.1
    12.7%
    47.8
    41.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 40.7
    Confidence Interval (2-Sided) 95%
    29.3 to 52.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4
    Description Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline Itch NRS Score >=4 in placebo and Ixekizumab arms. Missing values were imputed by NRI. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 40 83
    Number [percentage of participants]
    20.0
    35.7%
    71.1
    61.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 51.1
    Confidence Interval (2-Sided) 95%
    35.3 to 66.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)
    Description DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 56 115
    Number [percentage of participants]
    23.2
    41.4%
    64.3
    55.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 41.1
    Confidence Interval (2-Sided) 95%
    27.0 to 55.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)
    Description NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis & nail matrix psoriasis by area of involvement in the nail unit. Both fingernail & toenail involvement were assessed.The nail is divided with imaginary horizontal & longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) & nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed & nail matrix psoriasis in each quadrant: 0 = None = present in one quadrant of nail = present in two quadrants of nail = present in three quadrants of nail = present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed & nail matrix from each quadrant (maximum of 8). Each nail is evaluated, & the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and post baseline NAPSI score in placebo and Ixekizumab arms. Least squares(LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, region, baseline sPGA score,baseline weight category, baseline value, visit, treatment-by-visit, & baseline-by-visit interactions as fixed factors.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 12 34
    Least Squares Mean (Standard Error) [score on a scale]
    0.17
    (5.331)
    -16.87
    (3.110)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -17.04
    Confidence Interval (2-Sided) 95%
    -28.70 to -5.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.747
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)
    Description The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent = Slight = Moderate = Severe = Severest Possible Percent of Scalp Involved: = <10% = 10% - 29% = 30% - 49% = 50% - 69% = 70% - 89% = 90% - 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease). LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and post-baseline PSSI score in placebo and Ixekizumab. LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 50 102
    Least Squares Mean (Standard Error) [score on a scale]
    -12.28
    (2.572)
    -27.64
    (2.320)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.36
    Confidence Interval (2-Sided) 95%
    -18.69 to -12.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.682
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)
    Description PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows: Erythema (E), Induration (I), & Desquamation (D):0 = None, 1 = Slight, 2 = Moderate, 3 = Severe, 4 = Very Severe Percent of Palm and Sole Area Covered: 0 = None, 1 = <10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease).
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline PPASI score in placebo and Ixekizumab arms. LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
    Arm/Group Title Placebo Ixekizumab
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 9 17
    Least Squares Mean (Standard Error) [score on a scale]
    6.89
    (3.37)
    -5.11
    (2.148)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.01
    Confidence Interval (2-Sided) 95%
    -20.11 to -3.90
    Parameter Dispersion Type: Standard Deviation
    Value: 3.853
    Estimation Comments
    13. Secondary Outcome
    Title Number of Participants With Anti-Ixekizumab Antibodies
    Description A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as: a participant with a >= 4-fold increase over a positive baseline antibody titer; or for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10.
    Time Frame Baseline through Week 48

    Outcome Measure Data

    Analysis Population Description
    All randomized participants from maintenance period (During maintenance period participants were on Ixekizumab treatment).
    Arm/Group Title Ixekizumab (Maintenance Period)
    Arm/Group Description Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
    Measure Participants 194
    Number [participants]
    56
    100%
    14. Secondary Outcome
    Title Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
    Description Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in Ixekizumab arm with week 12 PK samples.
    Arm/Group Title Ixekizumab
    Arm/Group Description Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Measure Participants 111
    Geometric Mean (Geometric Coefficient of Variation) [microgram per milliliter (μg/mL)]
    3.03
    (106)
    15. Secondary Outcome
    Title Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)
    Description PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab Open-Label Etanercept
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
    Measure Participants 19 38 30
    Number [percentage of participants]
    26.3
    47%
    84.2
    73.2%
    63.3
    211%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixekizumab, Open-Label Etanercept
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.089
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 20.9
    Confidence Interval (2-Sided) 95%
    0.1 to 41.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)
    Description Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    Arm/Group Title Placebo Ixekizumab Open-Label Etanercept
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
    Measure Participants 19 38 30
    Number [percentage of participants]
    5.3
    9.5%
    76.3
    66.3%
    53.3
    177.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixekizumab, Open-Label Etanercept
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.070
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 23.0
    Confidence Interval (2-Sided) 95%
    0.6 to 45.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Up to 132 Weeks
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    Arm/Group Title PBO (Double-Blinded Treatment Period) IXEQ4W (Double-Blinded Treatment Period) ETN (Double-Blinded Treatment Period) PBO/IXEQ4W (Maintenance Period) IXEQ4W/IXEQ4W (Maintenance Period) ETN/IXEQ4W (Maintenance Period) PBO/IXEQ4W/IXEQ4W (Extension Period) IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) ETN/IXEQ4W/IXEQ4W (Extension Period) PBO (Randomized Withdrawal Period) IXEQ4W (Randomized Withdrawal Period) IXEQ4W_Re-Treatment (Randomized Withdrawal) Period PBO (Post-Treatment Follow-Up) IXEQ4W (Post-Treatment Follow-Up) ETN (Post-Treatment Follow-Up)
    Arm/Group Description Participants received matching placebo for Ixekizumab by subcutaneous injection. Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period. Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period. Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab. Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels. Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels. Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
    All Cause Mortality
    PBO (Double-Blinded Treatment Period) IXEQ4W (Double-Blinded Treatment Period) ETN (Double-Blinded Treatment Period) PBO/IXEQ4W (Maintenance Period) IXEQ4W/IXEQ4W (Maintenance Period) ETN/IXEQ4W (Maintenance Period) PBO/IXEQ4W/IXEQ4W (Extension Period) IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) ETN/IXEQ4W/IXEQ4W (Extension Period) PBO (Randomized Withdrawal Period) IXEQ4W (Randomized Withdrawal Period) IXEQ4W_Re-Treatment (Randomized Withdrawal) Period PBO (Post-Treatment Follow-Up) IXEQ4W (Post-Treatment Follow-Up) ETN (Post-Treatment Follow-Up)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/56 (0%) 0/115 (0%) 0/30 (0%) 0/53 (0%) 0/113 (0%) 0/28 (0%) 0/34 (0%) 0/68 (0%) 0/9 (0%) 0/33 (0%) 0/34 (0%) 0/33 (0%) 0/6 (0%) 0/166 (0%) 0/2 (0%)
    Serious Adverse Events
    PBO (Double-Blinded Treatment Period) IXEQ4W (Double-Blinded Treatment Period) ETN (Double-Blinded Treatment Period) PBO/IXEQ4W (Maintenance Period) IXEQ4W/IXEQ4W (Maintenance Period) ETN/IXEQ4W (Maintenance Period) PBO/IXEQ4W/IXEQ4W (Extension Period) IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) ETN/IXEQ4W/IXEQ4W (Extension Period) PBO (Randomized Withdrawal Period) IXEQ4W (Randomized Withdrawal Period) IXEQ4W_Re-Treatment (Randomized Withdrawal) Period PBO (Post-Treatment Follow-Up) IXEQ4W (Post-Treatment Follow-Up) ETN (Post-Treatment Follow-Up)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/56 (0%) 1/115 (0.9%) 1/30 (3.3%) 3/53 (5.7%) 7/113 (6.2%) 1/28 (3.6%) 0/34 (0%) 2/68 (2.9%) 0/9 (0%) 0/33 (0%) 3/34 (8.8%) 0/33 (0%) 0/6 (0%) 1/166 (0.6%) 0/2 (0%)
    Gastrointestinal disorders
    Crohn's disease 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 2/113 (1.8%) 2 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 1/166 (0.6%) 1 0/2 (0%) 0
    Diarrhoea 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Inflammatory bowel disease 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 1/53 (1.9%) 1 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Vomiting 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    General disorders
    Pyrexia 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Infections and infestations
    Furuncle 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Herpes zoster oticus 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 1/28 (3.6%) 1 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Otitis media acute 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Tonsillitis 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 1/53 (1.9%) 1 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Injury, poisoning and procedural complications
    Accidental overdose 0/56 (0%) 0 1/115 (0.9%) 1 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Ankle fracture 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Overdose 0/56 (0%) 0 0/115 (0%) 0 1/30 (3.3%) 1 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Postoperative ileus 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Rib fracture 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Road traffic accident 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Splenic rupture 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Investigations
    Glucose tolerance decreased 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 2/113 (1.8%) 2 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Astrocytoma 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Nervous system disorders
    Epilepsy 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 0/36 (0%) 0 0/63 (0%) 0 0/18 (0%) 0 1/35 (2.9%) 1 0/61 (0%) 0 0/17 (0%) 0 0/22 (0%) 0 0/37 (0%) 0 0/3 (0%) 0 0/17 (0%) 0 0/23 (0%) 0 0/19 (0%) 0 0/2 (0%) 0 0/104 (0%) 0 0/1 (0%) 0
    Renal and urinary disorders
    Renal haematoma 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured 0/36 (0%) 0 0/63 (0%) 0 0/18 (0%) 0 0/35 (0%) 0 1/61 (1.6%) 1 0/17 (0%) 0 0/22 (0%) 0 0/37 (0%) 0 0/3 (0%) 0 0/17 (0%) 0 0/23 (0%) 0 0/19 (0%) 0 0/2 (0%) 0 0/104 (0%) 0 0/1 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Other (Not Including Serious) Adverse Events
    PBO (Double-Blinded Treatment Period) IXEQ4W (Double-Blinded Treatment Period) ETN (Double-Blinded Treatment Period) PBO/IXEQ4W (Maintenance Period) IXEQ4W/IXEQ4W (Maintenance Period) ETN/IXEQ4W (Maintenance Period) PBO/IXEQ4W/IXEQ4W (Extension Period) IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) ETN/IXEQ4W/IXEQ4W (Extension Period) PBO (Randomized Withdrawal Period) IXEQ4W (Randomized Withdrawal Period) IXEQ4W_Re-Treatment (Randomized Withdrawal) Period PBO (Post-Treatment Follow-Up) IXEQ4W (Post-Treatment Follow-Up) ETN (Post-Treatment Follow-Up)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/56 (25%) 49/115 (42.6%) 7/30 (23.3%) 33/53 (62.3%) 76/113 (67.3%) 18/28 (64.3%) 20/34 (58.8%) 43/68 (63.2%) 5/9 (55.6%) 15/33 (45.5%) 22/34 (64.7%) 11/33 (33.3%) 2/6 (33.3%) 9/166 (5.4%) 0/2 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/56 (0%) 0 6/115 (5.2%) 6 0/30 (0%) 0 1/53 (1.9%) 1 3/113 (2.7%) 5 1/28 (3.6%) 1 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 1/33 (3%) 1 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Diarrhoea 1/56 (1.8%) 2 5/115 (4.3%) 7 0/30 (0%) 0 3/53 (5.7%) 3 5/113 (4.4%) 6 1/28 (3.6%) 1 1/34 (2.9%) 1 3/68 (4.4%) 7 0/9 (0%) 0 1/33 (3%) 1 2/34 (5.9%) 4 2/33 (6.1%) 2 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Irritable bowel syndrome 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 1/9 (11.1%) 1 0/33 (0%) 0 0/34 (0%) 0 1/33 (3%) 1 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Nausea 1/56 (1.8%) 1 6/115 (5.2%) 6 0/30 (0%) 0 3/53 (5.7%) 3 8/113 (7.1%) 9 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 1/33 (3%) 1 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Vomiting 1/56 (1.8%) 1 5/115 (4.3%) 5 0/30 (0%) 0 3/53 (5.7%) 3 7/113 (6.2%) 8 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 2/34 (5.9%) 2 2/33 (6.1%) 2 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    General disorders
    Injection site reaction 0/56 (0%) 0 11/115 (9.6%) 16 0/30 (0%) 0 8/53 (15.1%) 16 20/113 (17.7%) 47 0/28 (0%) 0 0/34 (0%) 0 2/68 (2.9%) 6 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 1/33 (3%) 3 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Pyrexia 0/56 (0%) 0 4/115 (3.5%) 6 1/30 (3.3%) 1 4/53 (7.5%) 4 4/113 (3.5%) 5 0/28 (0%) 0 1/34 (2.9%) 1 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Infections and infestations
    Bronchitis 0/56 (0%) 0 0/115 (0%) 0 1/30 (3.3%) 2 1/53 (1.9%) 1 0/113 (0%) 0 1/28 (3.6%) 1 3/34 (8.8%) 3 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 1/6 (16.7%) 1 0/166 (0%) 0 0/2 (0%) 0
    Cellulitis 1/56 (1.8%) 1 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 1/6 (16.7%) 1 0/166 (0%) 0 0/2 (0%) 0
    Conjunctivitis 0/56 (0%) 0 3/115 (2.6%) 3 0/30 (0%) 0 4/53 (7.5%) 5 6/113 (5.3%) 7 1/28 (3.6%) 2 1/34 (2.9%) 1 2/68 (2.9%) 2 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 1/33 (3%) 1 0/6 (0%) 0 1/166 (0.6%) 1 0/2 (0%) 0
    Folliculitis 0/56 (0%) 0 1/115 (0.9%) 1 0/30 (0%) 0 0/53 (0%) 0 4/113 (3.5%) 5 0/28 (0%) 0 1/34 (2.9%) 1 4/68 (5.9%) 4 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 1/33 (3%) 1 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Gastroenteritis viral 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 4/113 (3.5%) 4 2/28 (7.1%) 2 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 1/6 (16.7%) 1 0/166 (0%) 0 0/2 (0%) 0
    Impetigo 0/56 (0%) 0 1/115 (0.9%) 1 0/30 (0%) 0 4/53 (7.5%) 4 7/113 (6.2%) 13 0/28 (0%) 0 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Influenza 0/56 (0%) 0 2/115 (1.7%) 2 2/30 (6.7%) 2 1/53 (1.9%) 1 4/113 (3.5%) 5 0/28 (0%) 0 1/34 (2.9%) 1 4/68 (5.9%) 5 1/9 (11.1%) 1 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 1/166 (0.6%) 1 0/2 (0%) 0
    Nasopharyngitis 4/56 (7.1%) 4 13/115 (11.3%) 15 0/30 (0%) 0 7/53 (13.2%) 9 16/113 (14.2%) 21 4/28 (14.3%) 6 0/34 (0%) 0 8/68 (11.8%) 10 0/9 (0%) 0 4/33 (12.1%) 4 11/34 (32.4%) 14 2/33 (6.1%) 2 0/6 (0%) 0 1/166 (0.6%) 1 0/2 (0%) 0
    Oral herpes 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 4/53 (7.5%) 4 1/113 (0.9%) 1 1/28 (3.6%) 1 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Pharyngitis 0/56 (0%) 0 2/115 (1.7%) 2 2/30 (6.7%) 2 2/53 (3.8%) 3 8/113 (7.1%) 12 4/28 (14.3%) 4 3/34 (8.8%) 3 2/68 (2.9%) 2 1/9 (11.1%) 1 2/33 (6.1%) 2 1/34 (2.9%) 1 2/33 (6.1%) 2 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Pharyngitis streptococcal 0/56 (0%) 0 2/115 (1.7%) 2 0/30 (0%) 0 2/53 (3.8%) 2 5/113 (4.4%) 5 0/28 (0%) 0 2/34 (5.9%) 2 3/68 (4.4%) 3 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 1/166 (0.6%) 1 0/2 (0%) 0
    Pharyngotonsillitis 0/56 (0%) 0 1/115 (0.9%) 1 0/30 (0%) 0 2/53 (3.8%) 3 3/113 (2.7%) 3 0/28 (0%) 0 1/34 (2.9%) 1 1/68 (1.5%) 1 1/9 (11.1%) 1 1/33 (3%) 1 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Skin infection 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 2/113 (1.8%) 2 0/28 (0%) 0 2/34 (5.9%) 2 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Tonsillitis 2/56 (3.6%) 2 1/115 (0.9%) 1 0/30 (0%) 0 1/53 (1.9%) 1 5/113 (4.4%) 9 4/28 (14.3%) 5 1/34 (2.9%) 1 4/68 (5.9%) 5 0/9 (0%) 0 1/33 (3%) 1 3/34 (8.8%) 3 2/33 (6.1%) 3 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Upper respiratory tract infection 4/56 (7.1%) 4 6/115 (5.2%) 7 0/30 (0%) 0 5/53 (9.4%) 8 13/113 (11.5%) 20 2/28 (7.1%) 2 10/34 (29.4%) 13 11/68 (16.2%) 13 0/9 (0%) 0 3/33 (9.1%) 3 1/34 (2.9%) 1 2/33 (6.1%) 2 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Viral infection 0/56 (0%) 0 2/115 (1.7%) 2 0/30 (0%) 0 4/53 (7.5%) 4 3/113 (2.7%) 4 0/28 (0%) 0 1/34 (2.9%) 1 1/68 (1.5%) 2 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Viral upper respiratory tract infection 0/56 (0%) 0 2/115 (1.7%) 2 0/30 (0%) 0 2/53 (3.8%) 3 4/113 (3.5%) 4 0/28 (0%) 0 1/34 (2.9%) 1 3/68 (4.4%) 4 0/9 (0%) 0 1/33 (3%) 1 3/34 (8.8%) 3 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Injury, poisoning and procedural complications
    Fall 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 2/34 (5.9%) 2 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Investigations
    Weight decreased 1/56 (1.8%) 1 0/115 (0%) 0 0/30 (0%) 0 1/53 (1.9%) 1 6/113 (5.3%) 6 0/28 (0%) 0 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 2/33 (6.1%) 2 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/56 (3.6%) 2 2/115 (1.7%) 2 0/30 (0%) 0 3/53 (5.7%) 4 4/113 (3.5%) 5 3/28 (10.7%) 3 0/34 (0%) 0 3/68 (4.4%) 3 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 1/33 (3%) 1 0/6 (0%) 0 1/166 (0.6%) 1 0/2 (0%) 0
    Back pain 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 1/53 (1.9%) 1 7/113 (6.2%) 8 1/28 (3.6%) 1 0/34 (0%) 0 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 1 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Nervous system disorders
    Headache 1/56 (1.8%) 2 12/115 (10.4%) 13 1/30 (3.3%) 1 2/53 (3.8%) 2 12/113 (10.6%) 15 1/28 (3.6%) 1 1/34 (2.9%) 1 6/68 (8.8%) 9 1/9 (11.1%) 1 1/33 (3%) 1 2/34 (5.9%) 4 1/33 (3%) 1 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Reproductive system and breast disorders
    Menstruation irregular 0/36 (0%) 0 0/63 (0%) 0 0/18 (0%) 0 0/35 (0%) 0 0/61 (0%) 0 1/17 (5.9%) 1 0/22 (0%) 0 0/37 (0%) 0 0/3 (0%) 0 0/17 (0%) 0 0/23 (0%) 0 0/19 (0%) 0 0/2 (0%) 0 0/104 (0%) 0 0/1 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion 1/56 (1.8%) 1 1/115 (0.9%) 1 0/30 (0%) 0 3/53 (5.7%) 3 1/113 (0.9%) 1 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Oropharyngeal pain 1/56 (1.8%) 1 3/115 (2.6%) 3 0/30 (0%) 0 4/53 (7.5%) 4 3/113 (2.7%) 3 0/28 (0%) 0 2/34 (5.9%) 2 2/68 (2.9%) 2 0/9 (0%) 0 0/33 (0%) 0 1/34 (2.9%) 2 1/33 (3%) 1 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Rhinitis allergic 0/56 (0%) 0 1/115 (0.9%) 1 0/30 (0%) 0 1/53 (1.9%) 1 1/113 (0.9%) 1 0/28 (0%) 0 3/34 (8.8%) 3 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Rhinorrhoea 0/56 (0%) 0 1/115 (0.9%) 1 0/30 (0%) 0 3/53 (5.7%) 5 0/113 (0%) 0 0/28 (0%) 0 1/34 (2.9%) 1 1/68 (1.5%) 1 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 1/56 (1.8%) 1 0/115 (0%) 0 0/30 (0%) 0 3/53 (5.7%) 3 2/113 (1.8%) 2 0/28 (0%) 0 1/34 (2.9%) 1 1/68 (1.5%) 1 1/9 (11.1%) 1 0/33 (0%) 0 2/34 (5.9%) 2 1/33 (3%) 1 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Psoriasis 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 1/53 (1.9%) 1 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 2/68 (2.9%) 3 1/9 (11.1%) 1 3/33 (9.1%) 3 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 4/166 (2.4%) 4 0/2 (0%) 0
    Urticaria 0/56 (0%) 0 2/115 (1.7%) 2 0/30 (0%) 0 0/53 (0%) 0 1/113 (0.9%) 1 1/28 (3.6%) 1 0/34 (0%) 0 0/68 (0%) 0 0/9 (0%) 0 0/33 (0%) 0 0/34 (0%) 0 2/33 (6.1%) 2 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0
    Surgical and medical procedures
    Maxillofacial operation 0/56 (0%) 0 0/115 (0%) 0 0/30 (0%) 0 0/53 (0%) 0 0/113 (0%) 0 0/28 (0%) 0 0/34 (0%) 0 0/68 (0%) 0 1/9 (11.1%) 1 0/33 (0%) 0 0/34 (0%) 0 0/33 (0%) 0 0/6 (0%) 0 0/166 (0%) 0 0/2 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03073200
    Other Study ID Numbers:
    • 16367
    • I1F-MC-RHCD
    • 2016-003331-38
    First Posted:
    Mar 8, 2017
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Aug 16, 2021